QUALITY

START 5 QUALITY

To ensure the highest quality services, our laboratories implemented and maintained internationally recognized quality standards. As North American Biomedical Institute (NABI) we cooperate with the European Biomedical Institute and we are a part of the Biomedical Institutes Group. European Biomedical Institute is:

 

GLP certified

ISO 17025 accredited

US FDA 21CFR58 compliant

GLP

Quality system, that defines a set of rules and criteria for studies that are planned, performed and monitored, and their results are recorded, reported and archived. It is possible to trace the course of the study or its complete reconstruction. The European Biomedical Institute is GLP certified.

ISO 17025

The quality management standard, implemented to standardize the technical requirements and requirements of the management system, intended for research laboratories in terms of testing and calibration. The objective of ISO 17025 is to promote the confidence in the operation of laboratories, to enable them to demonstrate they operate competently, and are able to generate valid results. The European Biomedical Institute is ISO 17025 accredited.

US FDA 21CFR58

Code of Federal Regulations of good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA.

According to the ISO 10993-1:2018, B.4.5.3 any testing to support a biological evaluation have to be conducted in appropriate quality systems. The quality systems controls applicable to biocompatibility testing are known as Good Laboratory Practices (GLP). GLP studies are carried out to defined quality standards in laboratories that are accredited in line with an internationally implemented governmental scheme. Those studies have to be conducted under a laboratory quality system compliant to ISO/IEC 17025 or an equivalent standard (GLP).

Furthermore, European Biomedical Institute is inspected and subject to constant supervision of the following Bodies:

  • Veterinary Inspectorate

  • Ethic Committee

  • Pharmaceutical Inspectorate

  • Ministry of Science and Higher Education

  • European Commission

If you have any further questions in terms of quality, please contact with us at contact@nabi.bio

Download glp certificate
Download iso certificate